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Fluoride Treatment

Silver Diamine Fluoride for Tooth Decay

N/A

Waitlist Available

Led By Richard Niederman, DMD

Research Sponsored by NYU College of Dentistry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will compare the benefits of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer sealants in preventing dental caries in children.

Eligible Conditions

Tooth Decay
Quality of Life

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arrest of dental caries as measured by clinical oral examination

Prevention of dental caries as measured by a clinical oral examination

Secondary outcome measures

Oral Health-Related Quality of Life

School attendance

Student achievement on standardized math and English exams

Side effects data

From 2020 Phase 3 trial • 98 Patients • NCT02601833

45%

Active (soft) Lesion

13%

Active (soft) Lesion with Progression

Radiographic signs of periapical infection

Reversible Pulpitis

Extraction

Hard (arrested) Lesion with Progression

100%

80%

60%

40%

20%

Study treatment Arm

Silver Diamine Fluoride

Conventional Caries Management

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simple PreventionExperimental Treatment2 Interventions

One drop (0.05 ml) of silver diamine fluoride (Advantage ArrestTM) solution at 38% concentration (2.24 F-ion mg/dose) will be dispensed per child. Posterior tooth surfaces to be treated will be dried, after which the SDF will be applied with a micro-brush to all asymptomatic carious lesions and to all pits and fissures on bicuspids and molar teeth for thirty seconds. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Group II: Complex preventionActive Control2 Interventions

Pits and fissures on all bicuspids and molar teeth will be sealed with glass ionomer sealants (GC Fuji IX). Glass ionomer sealants (interim therapeutic restorations) will also be placed on all frank asymptomatic carious lesions. Fluoride varnishes (5% NaF) will then be applied to all teeth. Dosage frequency will be twice-yearly.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silver Diamine Fluoride

2019

Completed Phase 3

~8880

Fluoride Varnishes

2019

N/A

~7420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU College of DentistryLead Sponsor

11 Previous Clinical Trials

5,544 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,989,358 Total Patients Enrolled

Boston UniversityOTHER

454 Previous Clinical Trials

9,934,152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this clinical investigation?

"Clinicaltrials.gov confirms that this particular medical trial is still open for enrolment and the study was published in February of 2019, with the most recent update taking place on September 29th 2022."

Answered by AI

How many test subjects have volunteered for this clinical trial?

"Affirmative, information hosted on clinicaltrials.gov confirms that this medical study is actively recruiting participants. This trial was first made available to the public on February 1st 2019 and has since been updated on September 29th 2022. The research team needs to recruit 14100 patients from a single site for this project."

Answered by AI

Is this experiment open to individuals aged 50 or older?

"This experimental medication demands that all potential participants are between 5 and 12 years of age. 93 trials require minors, while 247 studies need adults 65 or older."

Answered by AI

Is it possible to become an active participant in this research?

"This dental trial is enrolling 14100 children aged between 5 and 12 years old who suffer from caries. The ideal candidate should meet the following criteria: coming from an economically disadvantaged background making up at least 80% of total participants, with all pupils in each school eligible to join the study."

Answered by AI

Recent research and studies

TrialsJournal

Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children: Study Protocol for a Cluster Randomized Controlled Trial

Ruff, Ryan Richard, and Richard Niederman. 2018. “Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children: Study Protocol for a Cluster Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-018-2891-1.

clinicaltrials.govStudy

Comparative Effectiveness of School-based Caries Prevention

Richard Niederman 2019. "Comparative Effectiveness of School-based Caries Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03442309.